Prosthetic liner with continuous distal end area

ABSTRACT

A tubular liner has an open proximal end and a closed-end distal area, and a fabric layer continuously defining an exterior surface of the liner without interruption. A polymeric layer having first and second surfaces is bonded to an interior surface of the fabric layer. A seam is formed by opposed sides of the fabric layer joined together and forming an excess portion directed toward the cavity of the liner. The excess portion is embedded in the polymeric layer.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority from U.S. provisionalapplication No. 61/163,952, filed on Mar. 27, 2009, the entirety ofwhich is incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to a prosthetic liner adapted to envelop aresidual limb. Specifically, the prosthetic liner has a seam definedalong sections of at least one fabric layer such that the exterior andinterior surfaces of the liner generally define continuous surfaceswithout interruption.

BACKGROUND

Prosthetic liners are well known in the art of the prosthetic devices.It is highly desirable that these liners conform closely to the residuallimb, accommodate surface contours and sub-surface bone elements of theresidual limb, and provide a comfortable cushion between the residuallimb and a hard socket of a prosthesis that is to be fitted over theresidual limb.

Special polymeric rubber or elastomer materials, such as siliconecompositions, have been formulated as suitable substances for prostheticliners. These elastomer materials having an appropriate hardness (orsoftness), elongation, tensile, and other properties, such asbio-inertness (resulting in no skin reaction), have been successfullyused for prosthetic liners.

A prosthetic liner which does not lock to a hard socket is generallyreferred to as a “cushion” liner. Cushion liners are designed toaccommodate residual limbs with fragile and exposed tissues, bonyprominences prone to pressure peaks, and conical residual limbs. Thesecushion liners can be geometrically configured to greatly decrease theneed for custom-made prosthetic liners. The distal end of these linersoften includes a distal end cap embedded into the liner.

A distal end cap may include components made from aluminum or othermetal, or rigid plastics such as Nylon. The end cap can creatediscomfort to the user since it interferes in allowing the liner toconform to the geometry of the limb, and impede pressure distribution ofthe liner over the residual limb. The end cap may also limitstretchability of the liner.

While effective solutions have been proposed and implemented, it isdesirable to improve the conformability of such liners or sleeves toincrease their ability to conform to irregularities on a residual limb,and accommodate a wider variety of limbs with fewer sizes of liners,while maintaining sufficient strength and durability. Moreover, it isparticularly desirable to provide a liner or sleeve arranged todistribute pressure of the liner against a prosthesis while providingsuperior stretchability over known liners and sleeves.

For the foregoing reasons, there is a need to provide improved linersand sleeves that impart improved conformability, pressure distribution,and stretchability while maintaining sufficient durability and strengthfor their requisite applications.

SUMMARY

In accordance with a first embodiment of the invention, a tubularprosthetic liner is adapted to envelop a residual limb. The liner has anopen proximal end arranged to permit entry of the residual limb into acavity of the liner defined by a continuous inner surface and aclosed-end distal end area arranged to receive the residual limb suchthat the residual limb is closely enveloped by the liner. The linerdefines an exterior surface generally conforming to the residual limb.

The liner includes an elasticized fabric layer defining outer and innersurfaces. In this embodiment, a seam is formed across the distal endarea of the liner and closes the distal end area of the fabric layer.The first fabric layer surface continuously defines the exterior surfaceof the liner, via the seam, at the distal end area of the liner withoutinterruption, such as by substantial recesses or protruding features.

According to this embodiment, the liner includes a first polymeric layerhaving inner and outer surfaces. The outer layer surface is intimatelyand continuously bonded to the inner surface of the fabric layer. Theliner also includes a second polymeric layer having inner and outersurfaces. The outer surface of the second polymeric layer surface iscontiguous and integrally secured to the inner surface of the firstpolymeric layer. The second polymeric layer is substantially thickerthan the first polymeric layer. The inner surface of the secondpolymeric layer defines the interior surface of the liner which iscontinuously smooth.

In a variation of this liner embodiment, the liner only includes asingle polymeric layer such that one of the first and second polymericlayers described above may be eliminated. In yet other variation, theliner is not limited to a single or two polymeric layers.

The seam is preferably formed by opposed edge portions of the fabriclayer joined by a welding element. The welding element may be apolymeric film which is contiguously and integrally joined to theopposed sides of the fabric layer. The seam may form an excess portiondirected toward the interior cavity of the liner but this excess portionis buried or embedded by the second polymeric layer.

The liner distal end area may have an arcuate outer wall defining radiiof curvature centered along a liner longitudinal axis of externalsymmetry, with the seam tracing at least along the radii of curvature.The seam may correspond exactly to the curvature of the liner distal endarea.

In a variation of the seam, the seam is defined by a stitched seam ofthe opposed edge portions of the fabric layer. The stitched seam onlyminimally protrudes from the exterior surface of the liner, therebyavoiding any substantially raised surfaces which could impede the usageof the liner in connection with a socket.

According to this embodiment, the fabric layer is an elasticized fabriclayer. The distal end area of the fabric layer is preferably arranged ina permanent distended condition such that the distal end area of thefabric layer has a continuous, surface without interruption.

The first polymeric layer may have a thickness that is substantiallyless than a thickness pertaining to the second polymeric layer.Moreover, the second polymeric layer may have a variable thicknessincreasing from the proximal end to the distal end area. The distal endarea thickness of the second polymeric layer may be generally uniform.

The first and second polymeric layers may include a silicone elastomer.The first and second polymeric layers may also each have differenthardnesses relative to one another; the second polymeric layer having alower hardness than the hardness of the first polymeric layer.

The second polymeric layer may comprise a composite including siliconeelastomer and silicone oil dispersed through the silicone elastomer.Also, the second polymeric layer may contain a plurality of hollowmicrospheres dispersed through the polymeric material.

The liner may include a distension controlling reinforcement matrixembedded in the second polymeric layer over the distal end area of theliner. The reinforcement matrix contains reinforcement elements thatprovide substantial stiffness against elongation of the liner in adirection along the liner length. These reinforcement elementspreferably do not provide substantial resistance against distension ofthe second polymeric layer in directions transverse to the liner length.

The reinforcement matrix is arranged so as not to interfere with theopposed sides of the fabric layer. According to one embodiment, theopposed sides of the fabric layer extend below in the polymeric layerbelow the reinforcement matrix.

In variations of the embodiment, the liner may be provided without areinforcement matrix.

Embodiments of the invention are not limited to a seam located at adistal end area of the liner. Instead, multiple fabric sections may becombined to form the fabric layer. These fabric sections are preferablyjoined in a similar manner to the aforementioned seam, either by weldingor stitching.

An exemplary embodiment includes a second fabric section secured to afirst fabric section. The second fabric section is surrounded in itsentirety by the first fabric section. The second fabric section may havegreater stiffness properties to accommodate certain anatomy of theresidual limb, such as a knee. The second fabric section may be arrangedin a variety of different shapes according to the different anatomy itis to correspond to, and it may likewise be oriented according todesired results from the multiple section fabric layer. Moreover, thefabric layer may include a plurality of different fabric sections,preferably each connected to one another according to the aforementionedseams.

In another exemplary embodiment, first and second fabric sections aresecured to each other along a longitudinal seam. The first fabricsection may correspond to the anterior portion of the residual limb andthe second fabric section may correspond to the posterior portion of theresidual limb.

In yet another exemplary embodiment, first and second circumferentialfabric sections are secured together along a circumferential seam. Thefirst fabric section may correspond to the distal end area of the linerso as to envelop the distal end area of the residual limb. The secondfabric section is arranged to at least envelop portions of the residuallimb above or directed more towards a proximal end of the liner.

In each of these embodiments, the first and second fabric sections mayhave different properties, for example stiffness, surface texture,thickness, hardness.

According to a variation of the embodiments described herein, anumbrella connector may be embedded into a liner having a seam. Theumbrella connector is generally adjacent to the interior surface of thefabric layer. The umbrella connector includes a connecting end thatextends through an opening defined across a distal end area of the linerand over the seam effectively removing part of the seam. A distal endcap may be formed or bonded along the exterior surface of the distal endarea of the liner, and surrounding a portion of the connecting end.

The liner may be formed with or without the distal end cap, and areinforcement matrix may be used in combination with the umbrellaconnector.

The embodiments described herein have superior cushioning and conform tothe distal end of residual limb so as to contribute to more equalpressure distribution. This significant benefit, as will become apparentbelow, will be understood by the provision of a distal end area seamthat eliminates the need for any distal end cap found in conventionalcomfort liners.

The numerous advantages, features and functions of the variousembodiments of the sleeve or liner with a continuous distal end areawill become readily apparent and better understood in view of thefollowing description and accompanying drawings. The followingdescription is not intended to limit the scope of the sleeve or liner,but instead merely provides exemplary embodiments for ease ofunderstanding.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view showing a first embodiment of the lineraccording to the invention.

FIG. 2 is a sectional elevational view showing an outer surface of theliner according to FIG. 1.

FIG. 3 is a bottom plan view showing an outer surface at a distal endarea of the liner according to FIG. 1.

FIG. 4 is an enlarged sectional view taken from FIG. 1.

FIG. 5 is a bottom plan view showing an outer surface at a distal endarea of a variation of the liner according to FIG. 1.

FIG. 6 is an elevational view showing an inside-out liner in aproduction step of the liner according to the embodiment of FIG. 1 priorto sealing the distal end area.

FIG. 7 is an elevational view showing an inside-out liner in aproduction step of the liner according to the embodiment of FIG. 1 aftersealing the distal end area.

FIG. 8 is an elevational view showing an embodiment of the liner havingfirst and second fabric sections forming a fabric layer.

FIG. 8A is a cross-sectional view taken along line 8A-8A in FIG. 8.

FIG. 9 is an elevational view showing another embodiment of the linerhaving first and second fabric sections forming a fabric layer.

FIG. 10 is an elevational view showing yet another embodiment of theliner having first and second fabric sections forming a fabric layer.

FIG. 11 is an elevational view showing an embodiment of a liner havingan umbrella connector.

FIG. 12 is a cross-sectional view of the liner of FIG. 11 taken alongline XII-XII without the silicone layer.

FIG. 13 is a bottom plan view of the liner of FIG. 11.

FIG. 14 is an elevational view showing another embodiment of a linerhaving an umbrella connector.

FIG. 15 is a sectional view taken from FIG. 14.

In the various figures, similar elements are provided with similarreference numbers. It should be noted that the drawing figures are notnecessarily drawn to scale, or proportion, but instead are drawn toprovide a better understanding of the components thereof, and are notintended to be limiting in scope, but rather provide exemplaryillustrations.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

The embodiments described herein may be adapted as a prosthetic liner,for example a cushion liner, which forms an interface between the skinof a residual limb and preferably rigid or semi-rigid socket. Theprosthetic liner stabilizes soft tissues, minimizes pistoning(stretching), helps to improve circulation, and adds comfort.

An example of a method for making a socket, as is readily understood bythe skilled artisan in the field of prosthetics, is described in U.S.Pat. No. 7,438,843, granted Oct. 21, 2008, the entirety of which isincorporated herein by reference.

In an embodiment of the liner, FIG. 1 schematically illustrates in across-section view a prosthetic liner 10 arranged as a tubular lineradapted to envelop a residual limb. The liner has an open proximal endarranged to permit entry of the residual limb into an interior cavity 19formed by the liner. The cavity is defined by a continuous interiorsurface IS and a closed-end distal end area such that the cavity isarranged to receive and closely envelop residual limb. The liner definesan exterior surface ES which generally conforms to the residual limb.

The liner 10 is formed in part by an elasticized fabric layer 12 alongits exterior surface ES, an intermediate, first polymeric layer 14, anda second polymeric layer 16 formed along the interior surface IS. A seam18 is formed across the distal end area 24 of the liner and closesopposed edge portions 20, 22 of the fabric layer 12 at the distal endarea 24 The entire assembly of the fabric layer, the first polymericlayer, and the second polymeric layer is at least freely radiallyelastically distendable.

The fabric layer 12 defines outer and inner surfaces whereby the outersurface continuously forms the exterior surface ES of the liner 10. Thefirst polymeric layer 14 has inner and outer surfaces, and the outersurface is intimately and continuously bonded to the inner surfaces ofthe fabric layer 12. The second polymeric layer 16 has inner and outersurfaces wherein the outer surface of the second polymeric layer 16 iscontiguous and integrally secured to the inner surface of the firstpolymeric layer 14.

The second polymeric layer 16 is substantially thicker than the firstpolymeric layer as evidenced by the thicknesses t₁, t₂ and t₃. Inparticular, the thickness of the second polymeric layer 16 issubstantially uniform at the distal end area 24 of the liner, andprogressively tapers towards the proximal end area 26.

The inner surface of the second polymeric layer 16 defines the innersurface IS of the liner 10. The inner surface of the second polymericlayer 16 is continuously smooth meaning that it is without interruptionand does not form any substantial recesses or protrusions, as shown inFIGS. 1 and 4. The smooth surface allows for pressure relief andcomfortably accommodates bony prominences, sensitive areas and scarredtissue of the residual limb.

The opposed edge portions 20, 22 are effectively embedded or buriedwithin the thickness t₃ of the second polymeric layer 16. The thicknesst₃ and extent of the excess of the opposed edge portions is arranged sothat the wearer does not feel the excess of the opposed edge portions20, 22 when the liner is worn on the residual limb.

The fabric layer is normally air permeable and may be formed from a flatknit elasticized fabric. The inner surface of the fabric layer is coatedwith the first polymeric layer 14 defined as a thin layer of curedsilicone elastomer preferably partially embedded in the fibers of thetextile without completely penetrating the textile. The fabric layer ispreferably seamless along the sides of the liner with the exception ofthe seam located at the distal end area.

The second polymeric layer is preferably a silicone elastomer that hashardness properties lower than hardness properties of the firstpolymeric layer. Moreover, the second polymeric layer preferably has athickness greater than a thickness of the first polymeric layer. Thesecond polymeric layer may include hollow thermoplastic microspheres,silicone oil, and/or one or more skin treatment agents. Such skintreatment agents may include petroleum jelly and aloe vera.

The fabric layer, and the first and second polymeric layers may beformed in accordance with any of the following U.S. Pat. Nos. 6,136,039,6,626,952, 6,485,776, 6,706,364, 7,001,563 and 7,118,602, each of whichare incorporated herein by reference in their entirety. The linerembodiments of the pending application may be configured to include anyof the features of the aforementioned patents

As depicted in FIGS. 1 and 4, an embodiment of the liner 10 may includea distension controlling reinforcement matrix 36 embedded in the secondpolymeric layer 16 over the distal end area 24 of the liner. Thereinforcement matrix 36 contains reinforcement elements that providesubstantial stiffness against elongation of the liner in a directionalong the liner length and do not provide substantial resistance againstdistension of the second polymeric layer in directions transverse to theliner length. The reinforcement elements may comprise interlocked fiberssuch as a circular knit tubular fabric that strongly resist longitudinalelongation but readily distends radially. An example of a reinforcementmatrix is described by U.S. Pat. No. 6,706,364.

In variations of the liner described herein, the liner may be providedwithout a reinforcement matrix.

It will be pointed out that the first and second polymeric layerconstruction may be substituted with a single polymeric layer, havingeither consistent material properties, or material properties akin tothe dual layer construction described above. In other variations, theliner may have additional polymeric layers to the first and secondpolymeric layer construction.

FIG. 2 depicts the distal end area 24 as having an arcuate outer walldefining a radius r₁ of curvature centered along a liner longitudinalaxis of external symmetry. The seam 18 preferably traces along the radiiof curvature and is generally restricted in length on opposed sides bythe height of the radius r₁. The seam 18 may be configured to extend onopposed sides of the liner 10, either above or below the height of theradius r₁.

As shown by FIG. 3, the distal end area 24 of this liner embodimentalong the exterior surface is continuous, without interruption. At leastthe distal end area 24 of the fabric layer 12 is arranged in a permanentdistended condition thereby preferably preventing the seam frompuckering or causing a recess to be formed along the distal end of theliner. Nonetheless, despite the permanent distended configuration, thefabric layer 12 is still capable of additional distension when the liner10 is placed over a residual limb.

In observing FIG. 4, the seam 18 is welded and air-tight. The seam 18 ispreferably formed by the opposed edge portions 20, 22 of the fabriclayer 12 joined by a welding element 32. Also shown are edge portions28, 30 of the first polymeric layer bonded to the opposed edge portions20, 22. The excess of the opposed edge portions 20, 22 is directedtoward the interior cavity 19 of the liner but this excess portion isembedded or buried by the second polymeric layer 16 so as to minimize oreliminate any notice by the wearer of when the liner is donned over theresidual limb.

According to one variation, the opposed edge portions are entirelyembedded in at least one of the polymeric layers.

It is preferred that the seam is minimized to avoid any discomfort thatcould arise with the buried excess portion of the seam on the interiorside of the liner. The seam can be modified in accordance with a varietyof different lengths depending on the geometry of the liner.

While the opposed edge portions 20, 22 are depicted as being generallyupright, the opposed edge portions 20, 22 can be adapted so that theyare folded or oriented askew in a manner to minimize protruding into thethickness of the second polymeric layer.

The welding element 32 may be a polymeric film which is contiguously andintegrally joined to the opposed sides of the fabric layer. A preferredwelding film is a polyurethane film under the trade name WALOPUR anddistributed by Epurex Films GmbH. A variety of the types of films thatmay be used include any type of thermoformable film, whether elastic orinelastic. Also, thermoset films may be used including those having twocomponents.

FIG. 5 illustrates an alternative embodiment of the seam 18 wherein theseam is formed by stitching the opposed edge portions 20, 22 of thefabric layer. The stitching 34 is exposed on the exterior surface ES ofthe distal end area 24. The stitching may be used in embodiments of theliner with or without the welding strip.

In observing FIGS. 6 and 7, production steps for forming the seam areexemplified. The liner 13 is in an early production form wherein thefabric layer 12 has been coated with the thin first polymeric layer 14.The liner 13 is depicted in an inside out configuration wherein thefirst polymeric layer 14 forms the exterior surface for the purpose offorming the seam.

The tubular fabric layer 12 is first cut according to a pattern ofexcess portion 15 accounting for the opposed edge portions 20, 22. Thepattern is such that it permits the seam to be formed and the finalizedliner forms the definitive shape of the liner 13 in a generallysymmetrical configuration. The distal end area 24 of the liner 13includes a slit 17 defined between the opposed edge portions 20, 22.

The welding film 32 is inserted between the opposed edge portions 20,22. The opposed edge portions 20, 22 are brought toward one anotherunder pressure and heat. The heat causes the film to bond the opposededge portions 20, 22 to each other. Any excess welding film protrudingfrom the seam and the opposed edge portions 20, 22 is trimmed from theliner 13.

Upon bonding of the opposed edge portions 20, 22, the seam 18 is formed.The excess portion 15 forms along the seam 18, such that when the liner13 is flipped to its normal configuration, the excess portion 15 extendsalong the interior of the liner and is generally directed to the cavityof the liner.

The seam serves to seal the distal end area of the liner therebyenabling molding of the second polymeric layer over the first polymericlayer. As a result, the second polymeric layer is subsequently moldedover the first polymeric layer after the seam is completely formed.

Embodiments of the invention are not limited to a seam located at adistal end area of the liner. Instead, multiple fabric sections may becombined to form the fabric layer. These fabric sections are preferablyjoined in a similar manner to the aforementioned seam, either by weldingor stitching.

In referring to FIGS. 8 and 8A, a liner 50 includes a second fabricsection 54 secured to a first fabric section 52. The second fabricsection 54 is surrounded in its entirety by the first fabric section 52,and joined along the seal 56. The seal 56 is arranged as described abovein reference to other embodiments presented herein, and includes awelding element 57. The inner surface of the liner 50 is delimited by alayer of polymeric material 55 consistent with the other embodimentsdescribed herein.

As an alternative to any of the embodiments described herein, the liner50 exemplifies a distal end cap 58 which may be secured to the distalend of the liner. The distal end cap may be mounted on the linerconsistent with the practice discussed in U.S. Pat. No. 7,001,563.

The second fabric section 54 may have greater stiffness properties toaccommodate certain anatomy of the residual limb, such as a knee. Thesecond fabric section 54 may be arranged in a variety of differentshapes according to the different anatomy it is to correspond to, and itmay likewise be oriented according to desired results from the multiplesection fabric layer. Moreover, the fabric layer may include a pluralityof different fabric sections, preferably each connected to one anotheraccording to the aforementioned seams.

FIG. 9 depicts another exemplary liner 60 wherein first and secondfabric sections 62, 64 are secured to each other along a longitudinalseam 66. The first fabric section 62 may correspond to the anteriorportion of the residual limb and the second fabric section 64 maycorrespond to the posterior portion of the residual limb.

In yet another exemplary embodiment, FIG. 10 illustrates a liner 70having first and second circumferential fabric sections 72, 74 securedtogether along a circumferential seam 76. The first fabric section 72may correspond to the distal end area of the liner so as to envelop thedistal end area of the residual limb. The second fabric section 74 isarranged to at least envelop portions of the residual limb above ordirected more towards a proximal end of the liner.

In each of these embodiments, the first and second fabric sections 72,74 may have different properties, for example stiffness, surfacetexture, thickness, hardness.

FIGS. 11 and 13 illustrate another embodiment of the liner 100 bearingsimilarity to the liner according to FIG. 1. This liner 100 includes atubular fabric layer 102, and a polymeric layer 104 defined by first andsecond polymeric layers 105, 107. The liner defines a seam 106 havingopposed edge portions 112, and arranged similarly to the seam describedin FIG. 1. The seam 106 effectively closes the end of the shaped fabriclayer 102, as in other embodiments described herein.

The liner of FIG. 11 includes an umbrella connector 108 embedded intothe silicone layer 104. The umbrella connector 108 has a connecting end114 having a threaded feature 116. As shown in FIG. 13, the connectingend 114 extends through an opening 122 formed through the fabric layer102 and across the seam 106. The connecting end 114 is arranged tosecure to various prosthetic devices and connectors known in the art ofprosthetic devices. Because of the opening, a section of the fabriclayer carrying the seam is removed while the seam remains intact. Adistal end cap 110 is formed or bonded to the distal end area of theliner 100, and surrounds a portion of the connecting end 114. The shapeof the umbrella connector is not limited to the variation shown hereinand may also correspond to the umbrella connector in combination with adistal end cap as taught in U.S. Pat. No. 6,485,776.

Referring to FIG. 12, the umbrella connector 108 is placed along theinner surface of the fabric layer 102 along its distal end. The umbrellaconnector 108 has a plurality of apertures 120 which facilitateembedding the umbrella connector 108 into the silicone layer 104. Aswith the other embodiments, the seam 106 includes the opposed edgeportions 112 which are sealed by the welding element 118. The umbrellaconnector may be embedded into the liner and the distal end cap may beformed as taught in U.S. Pat. No. 6,485,776.

As illustrated in FIG. 14, another embodiment of a liner 200 includes anumbrella connector 208 in combination with a reinforcement matrix 210.The liner 200 includes a fabric layer 202, and first and secondpolymeric layers 203, 204. The reinforcement matrix 210 is locatedbetween the first second polymeric layers 203, 204. The second polymericlayer includes first and second layer portions 205, 207 on opposed sidesof the umbrella connector 208. As depicted, the second layer portion 207forms the majority of the thickness of the second polymeric layer 206.

The umbrella connector 210 in FIGS. 14 and 15 is arranged in a similarmanner as in the liner 100 according to FIG. 11. Specifically, the liner200 includes a seam 206 with opposed edge portions 212 embedded in atleast one of the first and second polymeric layers 203, 204. Theumbrella connector 210 includes a connecting end 214 which protrudesthrough an opening 222 formed through the fabric layer 202 and acrossthe seam 206. The connecting end 214 includes a threaded feature 222 forsecuring to prosthetic devices.

By using a fabric layer closed at the distal end by a seam and thensubsequently, forming a hole through the fabric layer for placement of aconnecting end of an umbrella connector, manufacturing steps areeliminated resulting in reduced costs for making the process. Acomparison can be made to the simplicity of the instant solution to theprocess described in U.S. Pat. No. 6,485,776.

Any of the liner embodiments described herein may be adapted toaccommodate a plurality of undulations formed along portions of theliner in accordance with the description of U.S. Pat. Nos. 7,169,189 and7,118,602, incorporated herein in their entirety by reference. Also, theliner embodiments may be configured to include a seal or seals describedin U.S. Pat. No. 7,025,793, and U.S. patent application publication2007/0123998, incorporated herein in their entirety by reference.

It will be understood that the aforementioned embodiments are notlimited to the described liner described herein. Instead, the featuresof one of the preferred embodiments of this disclosure may readily becombined with those of another or other embodiments of the presentdisclosure without departing from the scope of the present invention.

It will be readily understood that the described embodiments of thedisclosure are exemplary only and various other features and detailscould be incorporated in the liner described herein without departingfrom the spirit and scope of the invention as defined in the appendedclaims. Further, while the liner has been described in connection to aprosthetic liner, the embodiments may be adapted for any suitableprosthetic or orthopedic uses.

The invention claimed is:
 1. A tubular prosthetic liner having an openproximal end and a closed-end distal area, and interior and exteriorsurfaces, the liner forming a cavity delimited by the interior surface,the liner adapted to envelop a residual limb, the liner comprising: afabric layer defining first and second surfaces, the first fabric layersurface continuously defining the exterior surface of the liner; atleast one elastomeric polymeric layer having first and second surfaces,the at least one elastomeric polymeric layer surface bonded to thesecond surface of the fabric layer; and a seam formed by opposed sidesof the fabric layer joined together, the opposed sides of the fabriclayer forming an excess portion directed toward the cavity of the linerand embedded in the at least one elastomeric polymeric layer, whereinthe opposed sides of the fabric layer are joined together by a weldingelement, the welding element is a polymeric film contiguously andintegrally joined along the opposed sides of the fabric layer.
 2. Theliner according to claim 1, wherein the fabric layer is an elasticizedfabric layer, the distal end area of the fabric layer arranged in apermanent distended condition.
 3. The liner according to claim 1,wherein the distal end area of the exterior and interior surfaces iscontinuous without interruption.
 4. The liner according to claim 1,wherein the at least one elastomeric polymeric layer includes: a firstcontinuous polymeric layer having first and second surfaces, the firstpolymeric layer surface bonded to the interior surface of the fabriclayer; and a second continuous polymeric layer having first and secondsurfaces, the first second layer surface being contiguous and integrallysecured to the second first layer surface, the second polymeric layerbeing thicker than the first polymeric layer, the second layer surfaceforming the interior surface as a continuously smooth surface.
 5. Theliner according to claim 4, wherein the second polymeric layer has ahardness substantially less than a hardness of the first polymericlayer.
 6. The liner according to claim 4, wherein the first polymericlayer has a thickness substantially less than a thickness pertaining tothe second polymeric layer.
 7. The liner according to claim 4, whereinthe second polymeric layer is a silicone elastomer.
 8. The lineraccording to claim 4, wherein the second polymeric layer is a compositeincluding a silicone elastomer and silicone oil dispersed through thesilicone elastomer.
 9. The liner according to claim 4, wherein thesecond polymeric layer contains a plurality of hollow microspheresdispersed through the silicone.
 10. The liner according to claim 4,wherein the second polymeric layer has a variable thickness increasingfrom the proximal end to the distal end area.
 11. The liner according toclaim 4, further comprising a distension controlling reinforcementmatrix embedded in the second polymeric layer over the distal end areaof the liner, the reinforcement matrix contains reinforcement elementsproviding substantial stiffness against elongation of the liner in adirection along the liner length without providing substantialresistance against distension of the second polymeric layer indirections transverse to the liner length.
 12. The liner according toclaim 4, wherein the excess portion is embedded in the second polymericlayer.
 13. The liner according to claim 1, wherein a distal end areathickness of the liner is generally uniform.
 14. The liner according toclaim 1, wherein the fabric layer comprises at least two fabric sectionsjoined along the seam, the two fabric sections having differentstiffness properties.
 15. The liner according to claim 1, wherein theliner distal end area has an arcuate outer wall defining radii ofcurvature centered along a liner longitudinal axis of external symmetry,the seam tracing at least along the radii of curvature.
 16. A tubularprosthetic liner having an open proximal end and a closed-end distalarea, and interior and exterior surfaces, the liner forming a cavitydelimited by the interior surface, the liner adapted to envelop aresidual limb, the liner comprising: a fabric layer defining first andsecond surfaces, the first fabric layer surface continuously definingthe exterior surface of the liner; at least one elastomeric polymericlayer having first and second surfaces, the at least one elastomericpolymeric layer surface bonded to the second surface of the fabriclayer; and a seam formed by opposed sides of the fabric layer joinedtogether, the opposed sides of the fabric layer forming an excessportion directed toward the cavity of the liner and embedded in the atleast one elastomeric polymeric layer, wherein the exterior surface ofthe liner is seamless outside of the distal end area, wherein theopposed sides of the fabric layer are joined together by a weldingelement, the welding element is a polymeric film contiguously andintegrally joined along the opposed sides of the fabric layer.
 17. Theliner according to claim 16, wherein the distal end area of the exteriorand interior surfaces is continuous without interruption.